Datwyler Pharma Packaging

Dr. Renaud Janssen ,
Senior Manager Global Scientific Affairs

Renaud Janssen, Ph.D. is the Senior Manager of Global Scientific Affairs at Datwyler Pharma Packaging. He frequently presents on international conferences on subjects related to elastomeric and aluminium/plastic closures for pharmaceutical applications. Renaud also serves on several standardisation and pharmacopoeia committees, as well as on industry task forces.

1. With your unparalleled experience in the pharmaceutical industrial sector, what would be the key milestones of your professional journey that you would like to share with us?

Major changes have taken place in the industry in general,and particularly in the packaging component industry that we are operating in. First, there is an increasing globalization of the industry. Our customers are becoming more global and mergers and acquisitions have become part of daily business life. Today, hardly any decisions are made without having an impact on global customers. Also, internally, less and less decisions can be made without affecting other areas of the company.

Regarding key milestones of my professional journey, I can definitely name the development of new rubber formulations such as FM457 and FM460 which both have very unique properties. Moreover,the development of the products in our Omniflex fluoropolymer coated product range have been important milestones. In fact, for an increasing number of drug products, a better or faster-to-market solution is found in coated stoppers such as our Omniflex stoppers.

2. You have been an indispensable part of Datwyler under both old and new managements. Kindly highlight the changes you’ve witnessed after Datwyler’s intervention and how it has ameliorated Helvoet Pharma’s holistic performance and output.

Changes in the company have made Datwyler a more global player. Considerable investments are constantly made to improve our global manufacturing footprint. This is also highly beneficial to our customers. Investments in ICT may be added to that. In terms of R&D, access to new analysis techniques was provided.

3. You have been, for years, intensively engrossed in the highly competitive market of Pharmaceutical R&D as well as Pharmaceutical Packaging for a century. In your opinion, as a long-standing pioneer, how much has the industry changed over time and in what ways?

Again,globalization plays a major role when talking about changes in our industry. Also, the pharma industry is now delegating actions to its packaging component vendors.Three decades ago, it was standard that pharma companies washed and siliconized closures. Tenyears later it became common that washing and siliconization were delegated to closure manufacturers, and at present more and more customers even delegate the sterilization of components to their vendors. However, this, of course, is only possible after vendors have accomplished the necessary pre-work in terms of documentation, auditing, quality agreements and so on. Another significant change that took place over the years is the need for more extensive documentation of materials, products and manufacturing as well as quality processes. Today, if something is not documented, it is considered to be non-existent. Lastly, we also need to consider the impact of the deployment of extractables and leachables and of changing control requirements.

4. Datwyler’s solutions and services that cater to the pharmaceutical and healthcare verticals are diverse. What made Datwyler Group branch into the medical sector?

It is a company policy to be active in niche sectors. This is why Datwyler, about 50 years ago, diversified into rubber for pharmaceutical applications. There are also other Datwyler business segments that reach out to niches in the market.

5. Considering the crucial significance of drug delivery, how would you outline the pre-emptive measures employed while manufacturing vials and syringes for utmost safety and security?

As a manufacturer of components for vials and syringes but also for elastomeric products for the diagnostics and medical device business, we can contribute to the achievement of safety and security in various ways. One of them is to develop materials which reduce the likelihood of interaction with a drug.Here, we talk about the development of new rubber compounds and coatings that are characterized by low extractables. In terms of product design, we can contribute by developing products whichare more robust with respect to their functionality. We are confident that our computer simulation capabilities will be very helpful in this respect. With regard to manufacturing, our processes are constantly being improved so that they continuously and reliably deliver products which are up to the required levels of microbiological and particulate cleanliness. We pay great attention and invest a lot of money to guarantee production in classified clean rooms with a large number of measures to prevent product contamination. In case contamination still occurs, we make intense efforts to correct this contamination in more downstream manufacturing steps. Thus, monitoring market requirements and being in close customer contact are essential for us.

6. Would you say that your processing solutions like camera inspection, RFS-RTU, surface treatments etc. are in line with the technological advancements in Pharma packaging today? How have they modernised?

We definitely think they are in line with current customer expectations.However, the word ‘current’ already indicates that we are not talking about something static. Customer expectations and requirements today will differ from those tomorrow and are very different to those of yesterday. Especially technological advancements of camera inspections permit to detect ever smaller sizes of contamination. This calls for an intensive and detailed follow-up of new techniques that are available. The same applies tothe scouting of new materials which can contribute to improvements that new rubber compounds and coatings can offer over existing materials.

7. How vastly and methodically has Datwyler invested in its Research and Development team, considering its multifarious range of offered compounds?

At present, R&D is focusing on the development of new materials, treatments and coatings as well as oncarrying out simulations by finite-element-analysis. The latter is a very recent addition. A number of other responsibilities that R&D had in the past were transferred to other departments. Moreover,a review on development priorities resulted in a prioritization of some projects, while other projects were assigned lower priority or were put on hold. Investments have been made and will keep being made in the future to expand the instrumental and analytical capabilities of Datwyler R&D.

8. There has been a boom in the sophistication of modern medical devices over the last few years. How do your products fair in the current burgeoning competition? Are there any new innovations in the pipeline?

First, I need to make clear that we are not directly operating in the medical devices market but in the market for components. However, our components of course have to follow the requirements new devices need to fulfill before they make it intothe market. The message here is to closely follow up with customers on those requirements and to adequately translate these into internal material, product design, manufacturing process and QA/QC requirements. This translation needs to be undertaken on a much more detailed level than in the past. For components related to more established packaging systems such as vials, customers today very often choose well established components with a proven track record and whichare now considered as standard components. In terms of innovations, we are used to thinking of material or product innovation. However, major innovations can also take place in the field of manufacturing technology. For example, when we take a look at the introduction of Datwyler’s FirstLine manufacturing concept, which was a real milestone for the entire industry. We are very committed to further improvements and its roll-out.

9. How has your experience been in the 5th Annual InnoPack—Pharma Confex? Was the response both qualitative and quantitative?

There was a good response level. Events like these allow us to show our commitment to the market, both the Indian market and the global market.

10. Could you kindly grant us a synopsis of your oration on “closure related drug product contamination” for a better comprehension of our readers?

Datwyler is committed to innovation in the field of materials and coatings as well as in the field of clean manufacturing technology. Our goal is to further raise the cleanliness of our products in everyrespect. This means cleanliness in terms of even lower extractables levels and in even less microbiological and particulate contamination.